Molecular monitoring versus standard clinical care in younger adults with acute myeloid leukaemia: results from the UK NCRI AML17 and AML19 randomised, controlled, phase 3 trials
Phase 3N = 637
- Population
- Patients aged 16 to 60 years with newly diagnosed AML and a molecular marker suitable for monitoring, in the UK, Denmark and New Zealand.
- Design
- Patients aged 16 to 60 years with a suitable molecular marker (NPM1 mutation or fusion gene) were randomised 2:1 to sequential molecular MRD monitoring during treatment and for 3 years after, or to standard clinical care with no monitoring; in the monitoring group treating physicians decided whether and how to use the results. Primary endpoint overall survival; prespecified analysis by molecular group. 637 patients randomised across the two trials (AML17: 289 monitoring and 144 no monitoring; AML19: 136 and 68). Registered as ISRCTN55675535 and ISRCTN78449203. Median follow-up 4.9 years.
- Primary endpoint
- OS
- Arms
- Molecular MRD monitoring (experimental): Sequential molecular MRD monitoring during treatment and for 3 years afterwards; treatment adjustment at the treating physician's discretion
- Standard clinical care (control): Standard clinical care with no molecular monitoring
- People
- Potter N, UK AML Research Network
OSHR 1.11 (95% CI 0.83–1.49)Δ 36-month OS−3 pointsOSHR 0.53 (95% CI 0.31–0.91)Δ 36-month OS+11 pointsOSHR 1.56 (95% CI 0.96–2.52)Δ 36-month OS−9 points
Show the numbers
| Endpoint | Analysis | Molecular MRD monitoring | Standard clinical care | Effect |
|---|---|---|---|---|
| OSRandomised patients in AML17 and AML19 | primarymedian follow-up 4.9 yearsPotter 2025 | 70% at 3 y (66–75%) | 73% at 3 y (68–80%) | HR 1.11 (95% CI 0.83–1.49)P=0.25Hazard ratio from the meta-analysis of the two trials, as published. |
| OSPrespecified subgroup: NPM1 mutation with FLT3-ITD | exploratoryPotter 2025 | 69% at 3 y (60–79%) | 58% at 3 y (45–74%) | HR 0.53 (95% CI 0.31–0.91)P=0.021One of three prespecified subgroups, as published; no correction for multiple testing is stated in the abstract. |
| OSPrespecified subgroup: NPM1 mutation without FLT3-ITD | exploratoryPotter 2025 | 69% at 3 y (62–77%) | 78% at 3 y (70–87%) | HR 1.56 (95% CI 0.96–2.52) |
| OSPrespecified subgroup: fusion gene transcripts | exploratoryPotter 2025 | 72% at 3 y (65–79%) | 77% at 3 y (68–87%) | HR 1.28 (95% CI 0.80–2.18) |
| Endpoint | Analysis | Molecular MRD monitoring | Standard clinical care | Effect |
|---|---|---|---|---|
| OSRandomised patients in AML17 and AML19 | primarymedian follow-up 4.9 yearsPotter 2025 | 70% at 3 y (66–75%) | 73% at 3 y (68–80%) | HR 1.11 (95% CI 0.83–1.49)P=0.25Hazard ratio from the meta-analysis of the two trials, as published. |
| OSPrespecified subgroup: NPM1 mutation with FLT3-ITD | exploratoryPotter 2025 | 69% at 3 y (60–79%) | 58% at 3 y (45–74%) | HR 0.53 (95% CI 0.31–0.91)P=0.021One of three prespecified subgroups, as published; no correction for multiple testing is stated in the abstract. |
| OSPrespecified subgroup: NPM1 mutation without FLT3-ITD | exploratoryPotter 2025 | 69% at 3 y (62–77%) | 78% at 3 y (70–87%) | HR 1.56 (95% CI 0.96–2.52) |
| OSPrespecified subgroup: fusion gene transcripts | exploratoryPotter 2025 | 72% at 3 y (65–79%) | 77% at 3 y (68–87%) | HR 1.28 (95% CI 0.80–2.18) |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| OS | 1.11 | 0.83–1.49 |
| OS | 0.53 | 0.31–0.91 |
| OS | 1.56 | 0.96–2.52 |
| OS | 1.28 | 0.8–2.18 |